Actalent • Cambridge, MA 02238
Job #2692080388
This role is HYBRID in Cambridge, MA and would require this individual to go on-site 2-3 days a week
Primary Responsibilities
Independently lead / manage clinical data management activities
Manage the communications with Sponsor
Oversee/contribute to Case Report Form development and database development and modifications
Responsible for all DM activities from start-up, conduct, and closeout
Lead/drive project deliverables and timelines and development teams and provide input into assay development, CRO selection and CRO management
Review and approve clinical trial documentation, such as protocol, timelines, Data Management Plan, Case Report Form Completion Guidelines, and other documentation
Draft, review and finalize internal data management documentation
Participate/lead Sponsor Acceptance Testing
Perform data cleaning and external vendor data reconciliation
Collaborate/work with Biostatisticians, Statistical Programmers, Medical Monitors and Clinical Operation Trial Lead, Pharmacovigilance, Regulatory Affairs, and other line functions/departments on clinical trials
Participate/lead in data management and cross-functional project clinical trial meetings
Develop and communicate requirements, timelines, strategy, and deliverables both internally and externally to ensure achievements are met
Manage/perform other duties as needed
B.S. in a scientific field with 10+ years of data management experience in CRO/pharma/biotech setting
At least 8+ years as a lead Clinical Data Manager
Proficient in clinical data collection, cleaning, and analysis for clinical trials
Experience in rare disease required; neuromuscular and / or pediatrics experience preferred
Experience working in an outsourced Data Management model
Experience with EDC systems is required; Medidata Rave experience a plus
Solid understanding of ICH GCP as well as general knowledge of industry practices and standards (CDASH, SDTM)
Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
Interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills
Ability to self-motivate and lead with confidence is critical
Excellent organizational and time management skills, sense of urgency
Strong analytical and problem-solving skills
Project Management skills
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.
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